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EMA’s Revised Guide On Additional Risk Minimization ‘Overly Detailed’

EU Pharma Association Pushes For Greater Use Of Digital Formats

 
• By Vibha Sharma

Executive Summary: The European pharma industry federation believes the advice provided in the updated draft EU guideline on additional risk minimization measures is far too detailed, resulting in a lack of focus, information overlap and confusion.

White pills on leaflet about possible side effects and overdose
Risk management of medicines involves activities to identify, characterize, prevent and minimize risks • Source: Alamy

Some sections of the European Medicines Agency’s revised pharmacovigilance guideline on additional risk minimization measures are “overly detailed” and their implementation could result in confusion, the EU pharmaceutical industry federation EFPIA has stated in its written feedback to the agency.

The updated draft guideline (GVP Module XVI) was issued for stakeholder consultation earlier this year. It included “pages and pages” of new information on how companies should select various additional...

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